Australian Good Manufacturing Practice

GMP Audits

Guidance Documents

Guidance on the GMP
Clearance of Overseas Medicine Manufacturers (May 2011)
This guidance document is intended to provide information to Sponsors and manufacturers on the documentary
evidence required to demonstrate acceptable GMP compliance for an overseas manufacturer, and, outline the
process for the submission of such evidence to the TGA for assessment. It is not intended to provide a
definitive list of the types of documentary evidence that are considered acceptable or
unacceptable.